Status:
TERMINATED
BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
Lead Sponsor:
Biogen
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of pa...
Detailed Description
Participants who complete this study through Week 52 will be offered the option to enter an Extension study under a separate protocol 211LE202 (NCT0193089).
Eligibility Criteria
Inclusion
- Key
- Documented diagnosis of systemic lupus erythematosus (SLE) according to current American College of Rheumatology (ACR) criteria. At least 4 ACR criteria must be documented, 1 of which must be a positive antinuclear antibody (ANA), anti Sm, or anti dsDNA antibody.
- Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis with either active or active/chronic disease, confirmed by biopsy within 3 months prior to Screening. Participants are permitted to have co existing Class V lupus nephritis. If a renal biopsy has not been performed within 3 months of the Screening Visit, one can be performed during the Screening Period after all other eligibility criteria have been confirmed. The local histological diagnosis must be confirmed by the central study pathologist.
- Must have proteinuria at Screening (from a 24 hour urine sample collection) defined as urinary protein:creatinine ratio (uPCR) \>1.0 mg/mg.
- Key
Exclusion
- Retinitis, poorly-controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE at Screening
- Estimated glomerular filtration rate (eGFR) \<30 mL/min per 1.73 m\^2 (calculated using the abbreviated Modification of Diet in Renal Disease equation) or the presence of oliguria or end-stage renal disease requiring dialysis or transplantation
- Subjects requiring dialysis within 12 months prior to Screening
- History of renal transplant
- Treatment with any biologic B-cell-depleting therapy (e.g., anti-CD20 \[rituximab\], anti-CD22 \[epratuzumab\], anti-BLyS/B-cell activating factor \[e.g., briobacept, belimumab\] therapy), or TACI-Ig within 12 months prior to Run-in Day 1.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT01499355
Start Date
July 1 2012
End Date
December 1 2015
Last Update
January 18 2017
Active Locations (58)
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1
Research Site
Torrance, California, United States, 90509
2
Research Site
Orlando, Florida, United States, 32806
3
Research Site
Boston, Massachusetts, United States, 02118
4
Research Site
Rochester, Minnesota, United States